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“Fundamentally, I think many agree that legislation will ultimately be needed, but the fact is policymakers have not yet coalesced around the direction the legislation should go,” says Epstein Becker Green attorney Brad Thompson, who specializes in FDA regulation of health tech.

“Contrary to the October 7 letter, the three federal agencies did not make recommendations in April,” Thompson tells VentureBeat. “Instead, they floated a draft of recommendations for comment. And they received tons of comments. And many of the comments disagreed with the draft recommendations . . . Many patient and professional groups took strong issue with some of the recommendations.”

Some of the commenters, including Thompson’s firm, took issue with the idea that health technologies can be divided into three neat categories. “We observed that health IT is being woven together in a very complex web of software, and it is utterly impossible to divide that into three discrete groups,” Thompson says. “Instead, we urged that the three agencies consider a regulatory strategy that acknowledges the network, the fact that software and hardware is all becoming interconnected.”